BEGIN:VCALENDAR
VERSION:2.0
PRODID:icalendar-ruby
CALSCALE:GREGORIAN
BEGIN:VEVENT
DTSTAMP:20240328T085735Z
UID:99d85f48-7757-4c9f-9509-d146d708de3c
DTSTART:20210603T110000
DTEND:20210604T110000
CLASS:PRIVATE
DESCRIPTION:Overview
\nThe international agreement to
assemble all Quality\, Safety and Efficacy information for a drug or biol
ogic product into a common format (called the CTD - Common Technical Docum
ent) has improved the speed and efficiency for companies working in global
development programs and clarified expectations by regulatory bodies. Ref
ormatting for multiple submissions is substantially limited. The CTD has i
mproved the regulatory review processes and enabled implementation of good
review practices. The eCTD has increased efficiency for reviewers and imp
roved submission times. Beginning in May 2021\, the eCTD will be required
in the US for all marketing applications.\n
\n
\nW
hy you should attend
\nThis webinar will provide you with in
formation to ensure that you are ready for implementing the mandated requi
rements of the CTD/eCTD. This webinar will provide you with information to
ensure that you are ready for implementing the mandated requirements of t
he CTD/eCTD.\n
\n
\nLecture 1 - CTD >\; eCTD\n\n\n - Overview of the drug development program and source of
relevant submission documents
\n - Discussion of the roles and resp
onsibilities for CTD preparation
\n - Review of the CTD content &
\; format requirements
\n - Implementing tools for the project manag
ement of CTD preparation and publishing
\n
\nLecture 2 - e
CTD Prepararation\n\n\n - Technical requirements for an eCT
D submission
\n - Document naming requirements
\n - Building t
he folder structure
\n - Publishing each document\, module &\; su
bmission
\n - Tools for tracking and managing eCTD content
\n Performing quality checks on the eCTD\n - Lifecycle management: U
pdating content (amendments\, supplements\, variations\, etc.)
\n
\n
\n
\nWho Will Benefit\n\n
\n
\nRegulatory Affairs
\nQuality Assurance
\nPharmacovigilance
\nProject Management
\nRegulatory Operations
\nAnyone respons
ible for providing content for the CTD
\n \;
SUMMARY:6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA
\,
BEGIN:VALARM
ACTION:DISPLAY
TRIGGER:-PT1H
SUMMARY:6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA
\,
END:VALARM
END:VEVENT
END:VCALENDAR